Clearance Summary
DUOSTAR received FDA 510(k) clearance under submission number K974170, sponsored by Mti Corp./ Electrostar S.A.-Haiti. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1998-09-30.
- Submission: K974170
- Applicant / Sponsor: Mti Corp./ Electrostar S.A.-Haiti
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 1998-09-30
Classification & Regulation
This clearance is catalogued under FDA product code GEI and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.